Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/27/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077745s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/30/2023 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/30/2023 | SUPPL-19 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
03/30/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
11/22/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/22/2019 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
06/22/2017 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
06/22/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
11/06/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/04/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
QUETIAPINE FUMARATE
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202152 | ACCORD HLTHCARE |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 201504 | ALKEM LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 091388 | AUROBINDO PHARMA LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077380 | DR REDDYS LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 204316 | HETERO LABS LTD V |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 090120 | HIKMA |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 205983 | IPCA LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 201109 | LUPIN LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 203359 | MACLEODS PHARMS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 206954 | PRINSTON INC |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078679 | SANDOZ |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 201190 | SUN PHARM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077745 | TEVA PHARMS |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202674 | UNICHEM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 090960 | ZENNOVA |
SEROQUEL | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020639 | ASTRAZENECA |
TABLET;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202152 | ACCORD HLTHCARE |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 201504 | ALKEM LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 091388 | AUROBINDO PHARMA LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077380 | DR REDDYS LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 204316 | HETERO LABS LTD V |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 090749 | HIKMA |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 205983 | IPCA LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 201109 | LUPIN LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 203359 | MACLEODS PHARMS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 206954 | PRINSTON INC |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078679 | SANDOZ |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 201190 | SUN PHARM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077745 | TEVA PHARMS |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202674 | UNICHEM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 090960 | ZENNOVA |
SEROQUEL | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020639 | ASTRAZENECA |
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202152 | ACCORD HLTHCARE |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 201504 | ALKEM LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 091388 | AUROBINDO PHARMA LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077380 | DR REDDYS LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 204316 | HETERO LABS LTD V |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 090749 | HIKMA |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 205983 | IPCA LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 201109 | LUPIN LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 203359 | MACLEODS PHARMS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 206954 | PRINSTON INC |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078679 | SANDOZ |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 201190 | SUN PHARM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077745 | TEVA PHARMS |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202674 | UNICHEM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 090960 | ZENNOVA |
SEROQUEL | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020639 | ASTRAZENECA |
TABLET;ORAL; EQ 150MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 201504 | ALKEM LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 091388 | AUROBINDO PHARMA LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 077380 | DR REDDYS LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078679 | SANDOZ |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 077745 | TEVA PHARMS |
TABLET;ORAL; EQ 200MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 202152 | ACCORD HLTHCARE |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 201504 | ALKEM LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 091388 | AUROBINDO PHARMA LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 077380 | DR REDDYS LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 204316 | HETERO LABS LTD V |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 090749 | HIKMA |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 205983 | IPCA LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 201109 | LUPIN LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 203359 | MACLEODS PHARMS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 206954 | PRINSTON INC |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 078679 | SANDOZ |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 201190 | SUN PHARM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 077745 | TEVA PHARMS |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 202674 | UNICHEM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | No | AB | 090960 | ZENNOVA |
SEROQUEL | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020639 | ASTRAZENECA |
TABLET;ORAL; EQ 300MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 202152 | ACCORD HLTHCARE |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 201504 | ALKEM LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 091388 | AUROBINDO PHARMA LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 077380 | DR REDDYS LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 204316 | HETERO LABS LTD V |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 090749 | HIKMA |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 205983 | IPCA LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 201109 | LUPIN LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 203359 | MACLEODS PHARMS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 206954 | PRINSTON INC |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 078679 | SANDOZ |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 201190 | SUN PHARM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 077745 | TEVA PHARMS |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 202674 | UNICHEM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 090960 | ZENNOVA |
SEROQUEL | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020639 | ASTRAZENECA |
TABLET;ORAL; EQ 400MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 202152 | ACCORD HLTHCARE |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 201504 | ALKEM LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 091388 | AUROBINDO PHARMA LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 077380 | DR REDDYS LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 204316 | HETERO LABS LTD V |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 090749 | HIKMA |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 205983 | IPCA LABS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 201109 | LUPIN LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 203359 | MACLEODS PHARMS LTD |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 206954 | PRINSTON INC |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 078679 | SANDOZ |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 201190 | SUN PHARM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 077745 | TEVA PHARMS |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 202674 | UNICHEM |
QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 090960 | ZENNOVA |
SEROQUEL | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020639 | ASTRAZENECA |